Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01329731
• Date of registration: 01/04/2011
• Prospective Registration: No
• Primary sponsor: Gaba International AG
• Public title: Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients
• Scientific title: White Spot Lesion Development in Post-orthodontic Patients Following Weekly Application of a 1.25% Fluoride Gel Compared to Placebo Over 6 Months
• Date of first enrolment: March 2011
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01329731
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent

- Healthy volunteers (=11 years) scheduled for bracket removal

- = 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding

Exclusion Criteria:

- Known hypersensitivity or allergy to study products and standard toothpaste
ingredients and/or dental material used in the present study

- Known hypersensitivity or allergy to placebo gel ingredients

- Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis

- Any illness/condition potentially affecting the study outcome at investigator's
discretion

- Known pregnancy or breast feeding during the course of the study



Age minimum: 11 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Tooth; Lesion, White Spot Lesions

Intervention(s)

Drug: negative control (placebo)

Drug: elmex® gelée

Primary Outcome(s)

WSL-size change [Time Frame: 12 weeks]

Secondary Outcome(s)

Caries activity [Time Frame: Baseline up to 24 weeks]

WSL index on all upper front teeth [Time Frame: Baseline up to 24 weeks]

DMFT index: Dental health of all teeth [Time Frame: Baseline, 24 weeks]

WSL-size change [Time Frame: Baseline up to 24 weeks]

Gingival bleeding index on all upper front teeth [Time Frame: Baseline up to 24 weeks]

Plaque index (Silness and Löe 1964)on all upper front teeth [Time Frame: Baseline up to 24 weeks]

WSL-brightness change [Time Frame: Baseline up to 24 weeks]

Secondary ID(s)

2010-020538-24

GASAS-1002X

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PD Dr. Christian Heumann